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Informational MHRA guidance update on withdrawal of Notified Bodies

dgrainger

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Notified bodies for medical devices

Withdrawal of notified body services
Background
The scope of designation of a notified body (which tasks it does) may change at any time. In certain situations, this can happen at short notice and in these cases, the validity of the CE certificates previously issued may be affected.
There are no specific provisions under current legislation regarding the ongoing validity of CE certificates in such a scenario. Therefore, MHRA has implemented a process so that manufacturers can keep placing products on the EU market while they transfer to a new notified body. This process is aligned to guidance provided by:
Who is this process for?
Manufacturers based in the UK, or those outside the UK with an authorised representative based in the UK, affected by closure or scope reduction of their notified body with a valid CE certificate under Directives 93/42/EC, 98/79/EC and 90/385/EC.
Support provided by MHRA
If you are eligible, MHRA may offer a grace period where you can continue to place products on the EU market until you find a new notified body. MHRA’s decision whether or not to support a manufacturer is made on a case-by-case basis. The offer is dependent on you meeting a number of conditions. This includes regular updates from you to enable MHRA to monitor progress made in transferring to a new notified body and status of CE certification. During the grace period if you fail to keep to the conditions, or if there is evidence of the devices not meeting the relevant safety requirements, we will withdraw the permission. If you gain CE certification before the end of the grace period, MHRA’s support will end, and you will no longer fall under MHRA’s oversight.
You can contact MHRA at [email protected] for further information.
Please note that this process does not replace the activities of a notified body and it is not applicable to manufacturers who can’t transition their certificates from Directives 93/42/EC, 98/79/EC and 90/385/EC to Regulations 2017/745 and 2017/246.
 
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